Effect of Probiotics on Functional Constipation in Adults

NCT04437147 | Completed DMC

• 1 other identifier: Fabiana Rosa
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Functional constipation is a symptom-based gastrointestinal disorder without an organic origin (eg, bowel obstruction). It has a prevalence of 14% in adults. Objective: The objective of trial is to evaluate the efficacy and safety of two different probiotic blends in adults subjects with functional constipation. Methods: A double-blind, randomized, placebo-controlled study will be conducted for up to two years to evaluate the efficacy of two different probiotic mixtures: (Mixture 1) Lactobacillus acidophilus, Bifidobacterium bifidum and Lactobacillus rhamnosus (3 billion CFU); (Mixture 2) Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus rhamnosus, Lactobacillus paracasei, Bifidobacterium longum, Bifidobacterium lactis, Lactobacillus defensis, Bifidobacterium animallis (8 billion CFU).

Conditions

Functional Constipation

Keywords

Lactobacillus; Bifidobacterium

Outcome Measures

Primary Outcomes (2)

• Changed in the number of Bowel movements. Changed for more than 3 per week was considered a clinical response.

  Changed number of bowel movements evaluated weekly

  30 days

• Change in the Bristol stool form scale at 4 weeks after Probiotics. Recovery to types 3-4 was considered a clinical response.

  The Bristol scale ranges from 1-7, with 1-2 being constipated, 3-5 normal and 6-7 diarrhea.

  30 days

Secondary Outcomes (3)

• Subject withdrawal

  30 days

• Adverse events

  30 days

• Serious adverse events

  30 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

a) Control placebo (P1) Component Vitamin C (Ascorbic acid) 45 mg,Vitamin B1 (Thiamine) 1.1 mg, Vitamin B2 (Riboflavin) 1.1 mg,Vitamin D-3 40,000,000 IU / GR (Cholecalciferol) 34 mcg, Magnesium hydroxide 0.3 g, Calcium Carbonate 0.5 g, Natural Vanilla Flavor Powder 0.03 g,Fos (Fructooligosaccharides) qsp 3 g, for 30 days, once a day by sachet

Dietary Supplement: Placebo

3 Billion CFU strains of probiotics

ACTIVE COMPARATOR

b) 3 Billion CFU (P2) Component Lactobacillus acidophilus LA 02 ID 1688 1 billion CFU,Bifidobacterium bifidum BB 01 ID 1722 1 billion CFU, Lactobacillus rhamnosus LR 04 ID 1132 1 billion CFU,Vitamin C (Ascorbic acid) 45 mg,Vitamin B1 (Thiamine) 1.1 mg, Vitamin B2 (Riboflavin) 1.1 mg,Vitamin D-3 40,000,000 IU / GR (Cholecalciferol) 34 mcg, Magnesium hydroxide 0.3 g, Calcium Carbonate 0.5 g, Natural Vanilla Flavor Powder 0.03 g,Fos (Fructooligosaccharides) qsp 3 g, for 30 days, once a day by sachet

Dietary Supplement: 3 Billion UFC strains of probiotics

8 Billion CFU strains of probiotics

ACTIVE COMPARATOR

c) 8 Billion UFC (P3) Component Lactobacillus paracasei LPC 00 ID 1076 1 billion CFU;Bifidobacterium longum BL 03 ID 1152 1 billion CFU; Bifidobacterium lactis BS 01 ID 1195 1 billion CFU;Lactobacillus casei LC 03 ID 1872 1 billion CFU; Bifidobacterium animalis LMG 10508 1 billion CFU; Lactobacillus acidophilus LA 02 ID 1688 1 billion CFU,Bifidobacterium bifidum BB 01 ID 1722 1 billion CFU, Lactobacillus rhamnosus LR 04 ID 1132 1 billion CFU,Vitamin C (Ascorbic acid) 45 mg,Vitamin B1 (Thiamine) 1.1 mg, Vitamin B2 (Riboflavin) 1.1 mg,Vitamin D-3 40,000,000 IU / GR (Cholecalciferol) 34 mcg, Magnesium hydroxide 0.3 g, Calcium Carbonate 0.5 g, Natural Vanilla Flavor Powder 0.03 g,Fos (Fructooligosaccharides) qsp 3 g, for 30 days, once a day by sachet

Dietary Supplement: 8 Billion UFC strains of probiotics

Interventions

Placebo DIETARY_SUPPLEMENT

Fibers with vitamins and minerals will be administered for 30 days once a day in sachets

Also known as: Group Placebo

Placebo

3 Billion UFC strains of probiotics DIETARY_SUPPLEMENT

Fibers with vitamins and minerals will be administered for 30 days once a day in sachets with 3 billion CFU strains of probiotics

3 Billion CFU strains of probiotics

8 Billion UFC strains of probiotics DIETARY_SUPPLEMENT

Fibers with vitamins and minerals will be administered for 30 days once a day in sachets with 8 billion CFU strains of probiotics

8 Billion CFU strains of probiotics

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of functional constipation according to Rome IV. Granting of written informed consent.

You may not qualify if:

• Presence of gastrointestinal diseases
• Ingestion of antibiotics or dietary supplements containing probiotics or prebiotics in the last 15 days
• Pregnancy.

Sponsors & Collaborators

• Luciane Cruz Lopes: lead

Study Sites (1)

Universidade de Sorocaba

Sorocaba, São Paulo, 19023000, Brazil

Location

Related Publications (1)

• Mitelmao FCR, Hackel K, Bergamaschi CC, Gerenutti M, Silva MT, Balcao VM, Vila MMDC. The effect of probiotics on functional constipation in adults: A randomized, double-blind controlled trial. Medicine (Baltimore). 2022 Oct 28;101(43):e31185. doi: 10.1097/MD.0000000000031185.

  PMID: 36316826 DERIVED

Study Officials

• Fabiana R MITELMAO, master

  UNIVERSIDADE DE SOROCABA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The phisician (care provider), the research subjects (participants) and outcome assessor (had access to the results) will be blinded. All groups received sachets with the same characteristics (taste and packaging) different only in the numbering of the manufacturing batches. The phisician separated each volunteer in according to lot number corresponding to the randomisation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator: Fabiana Cristina Rosa Mitelmão

Model Details: Interventions: in particular, subjects were divided into 3 groups: i) 50 subjects in the group A will receive placebo, ii) 50 subjetcs in the group B will receive mixed L. acidophilus LA 02 ID 1688, B. bifidum BB 01 ID 1722 and L. rhamnosus LR 04 ID 1132 (1 x 10⁹ colony-forming units/d of each strain) and 50 subjects em the group C will receive L. acidophilus LA 02 ID 1688, B. bifidum BB 01 ID 1722, L. rhamnosus LR 04 ID 1132, L. paracasei LPC 00 ID 1076, B. longum BL 03 ID 1152, B. lactis BS 01 ID 1195, L. casei LC 03 ID 1872, B. animalis LMG 10508 (1 x 10⁹ colony-forming units/d of each strain) for 30 days. At the beginning of the interventional study, the healthy status of volunteers will be evaluated by a complete, laboratory and by the clinical evaluation by the doctor using as reference ROMA IV for intestinal constipation. Exclusion criteria will be items of gastrointestinal diseases, pregnant and antibiotic intake.

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 18, 2020
• Study Start: March 11, 2020
• Primary Completion: November 30, 2020
• Study Completion: January 28, 2021
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

BR (1)